The European Commission (EC) responsible for medical devices regulatory framework has published an official notice informing about its proposal to roll out the new In Vitro Diagnostic Medical Devices Regulation to ensure uninterrupted availability of vitally important medical devices.
The proposed changes are based on the new needs and regulatory challenges arising in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”. During the pandemic associated thereto, the healthcare system of the EU Member States faced numerous issues, and some of them are legal. Thus, it was proposed to amend the existing regulatory framework for in vitro diagnostic medical devices to improve the possibility of the healthcare system to withstand the overload it faces. It is also important to mention that the proposal does not change any requirements of the In Vitro Diagnostic (IVD) Regulation in substance but only changes the transitional provisions to allow the Regulation’s progressive rollout. In particular, it was suggested to link the transitional period to the class of medical devices under the applicable risk-based classification. The Regulation itself provides numerous improvements: for instance, it provides that conformity assessment bodies (also referred to as “notified bodies”) will be responsible for ensuring that any medical devices intended to be placed on the market are fully compliant with the applicable regulatory requirements in terms of the safety and performance.
The EC acknowledges that the lack of notified bodies duly designated to carry out conformity assessment for in vitro diagnostic medical devices could result in a delay in the review of new marketing applications and, consequently, potential shortages in the supply of vitally important healthcare products. To mitigate risks associated thereto, it was proposed to implement a new regulatory framework in the course of a consistent process ensuring that new regulatory requirements IVD products are subject to and a slight increase in regulatory burden for their manufacturers would not impact adversely the uninterrupted availability of such devices. The Commission also mentions that the scope of suggested changes does not cover CE-marked medical devices that are not subject to conformity assessment to be carried out by notified bodies, as well as to those devices that are entirely new and haven’t been placed on the market before. At the same time, special rules will apply for medical devices manufactured to meet the internal needs of healthcare institutions (the concept of “in-house devices”).
It is important to mention that before it will become effective, the proposal should be adopted by the European Parliament and Council.
The In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) is initially intended to improve the regulatory framework for in vitro diagnostic medical devices that are actively used in a clinical decision-making process. The new Regulation will supersede Directive 98/79/EC which is currently governing the regulatory matters related to IVD products. It is expected that the new regulatory framework will improve the level of health protection, and also create favorable conditions for all the parties involved.
As it was mentioned before, the most important changes to be introduced under the new Regulation are related to the role of notified bodies. In particular, the scope of in vitro diagnostic medical devices that should be subject to conformity assessment to be carried out by notified bodies would be expanded significantly. Thus, the scope of new legislation would cover some of the medical devices that were previously subject to a simplified approach.
Later in May 2021, the European Parliament has raised a question regarding the way the transition to a new regulatory framework should be performed to ensure uninterrupted availability of medical devices and prevent shortages. Similar concerns were raised by medical device manufacturers and other parties involved in operations with medical devices. This created grounds for the proposal described herein.
Proposal: Key Points
According to the clarifications provided by the European Commission, it is proposed to:
- Extend the existing transitional period for devices covered by a certificate issued under Directive 98/79/EC;
- Introduce tailored transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under Regulation (EU) 2017/746; and
- Introduce a transitional period for the requirements for devices manufactured and used within the same health institution (“in-house devices”) to provide these institutions with the additional time necessary to achieve compliance with the new regulatory requirements.
The European Commission also mentions that the sole postponement of implementation (as it was with the Medical Devices Regulation 2017/745 or the MDR) would not be sufficient to solve the issues the industry and healthcare sector, in general, could face. It is pointed out that the main issue that remains unresolved is that the expected number of in vitro diagnostic medical devices that due to regulatory changes should be subject to conformity assessment is far beyond the capabilities of notified bodies duly designated under the new framework. To overcome this challenge, it was suggested to expand the scope of medical devices subject to conformity assessment in several steps, provided that high-risk ones will have higher priority. Simultaneously the transitional period for medical devices already allowed for marketing and use under Directive 98/79/EC would be extended. As a result, the transitional periods for both MDR and IVDR will end at the same time, which will allow the regulatory bodies involved to optimize their workload.
The comparison provided in the document shows that about 78% of all in vitro diagnostic medical devices would be subject to conformity assessment under the new framework, while it is about 8% under existing one. Moreover, there are only 6 notified bodies duly designated to carry out conformity assessment of IVD products under the IVDR, while there are 22 notified bodies entitled to assess medical devices under the respective Directive.
According to the proposal, for the period needed to expand the capacity of notified bodies, a balance should be struck between the limited available capacity and a high level of public health protection. As described hereinabove, this will be implemented by establishing different transitional periods for medical devices depending on their class under the risk-based classification.
In summary, the proposal of the European Commission provides for the implementation of additional measures necessary to ensure a smooth transition to the new regulatory framework. As suggested by the EC, the approach to be applied should be based on the type of medical device in question. It is expected that the proposed changes would optimize the workload of conformity assessment bodies and regulating authorities to prevent shortages in the supply of vitally important medical devices.
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